The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has published a positive report on Gilead’s experimental once-daily dose of the combination therapy Harvoni, which includes the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults. This CHMP report followed Gilead’s accelerated review procedure for therapeutic products that may have a critical impact on public health. The CHMP’s recommendation will now be reviewed by the European Commission, which is the authority that approves medicines to be commercialized throughout the 28 countries of the European Union.

Hepatitis C (HCV) is a disease of the liver caused by the hepatitis C virus, which is a blood-borne virus. This infection can induce liver damage, and patients that are chronically infected will probably develop liver pathologies, such as cirrhosis (destruction of normal liver tissue) and cancer, and will need liver transplantation. In Europe, approximately nine million people are infected with HCV, with the genotype 1 being the most common form of HCV and accounting for 60% of infections in the world, followed by genotypes 2 and 3, while genotypes 4-6 are more predominant in Asia and Africa.

The Marketing Authorization Application (MAA) for Harvoni was based on data from three Phase 3 studies (ION-1, ION-2 and ION-3) that evaluated Harvoni therapy, with or without ribavirin, for 8, 12 or 24 weeks in 2,000 genotype 1 HCV patients with compensated liver disease, i.e. patients with a functional diseased liver, and cirrhotic and non-cirrhotic patients that were never given the HCV treatment and had failed prior treatment with an interferon-based therapy, including treatments with an HCV protease inhibitor. The application also included preliminary data from the SOLAR-1 and ELECTRON-2 trials that were done, respectively, in decompensated cirrhotic patients urgently requiring a liver transplant, pre- and post-transplant patients, and genotype 3 patients, as well as phase 2 studies in genotype 4 patients.

Sofosbuvir (SOF), as a single therapy, was approved by regulatory authorities in the United States, European Union, Australia, Canada, New Zealand, Egypt, Switzerland, and Turkey on January 16, 2014 under the trademark Sovaldi. In the European Union, Harvoni is an experimental compound, and its safety and efficacy has not been yet established.

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